Indian Journal of Chemical Technology, Vol.14, No.6, 611-615, 2007
Sensitive spectrophotometric methods for the determination of pantoprazole sodium in pharmaceuticals using bromate-bromide, methyl orange and indigo carmine as reagents
,two new sensitive spectrophotometric methods are described for the determination of pantoprazole sodium sesqui hydrate (PNT) bromate-bromide mixture and two dyes, methyl orange and indigocarmine, as reagents. The methods hydrate (PNT) using entail the addition of a known excess of bromate-bromide mixture to PNT in hydrochloric acid medium followed by determination of residual bromine by reacting with a fixed amount 4 either methyl orange and measuring the absorbance at 520 nm (Method A) or indigo carmine and measuring file absorbance at 610 nm (Method B). In both methods, the amount of bromine reacted corresponds to the amount. of PNT. The absorbance is found to increase linearly with concentration of PNT,. Under the optimum conditions, PNT could be assayed in the concentration ranges 0.12-1.50 and 0.5-6.0 mu g mL(-1) by method A and method B, respectively. The apparent molar absorptivities are calculated to be 1.8x10(5) and 4.1 x 10(4) L mol(-1) cm(-1) for method A and method B, respectively, and the corresponding Sandell sensitivity values are 0.002 and 0.011 mu g cm(-2). The limits of detection and quantification are also reported for both methods. Intra-day and inter-clay precision and accuracy of the developed methods were evaluated LIS per the current ICH guidelines. The methods were successfully applied to the assay of PNT in its tablet formulation and file results were compared with those of a reference method by calculating the Student's-t-value and F-value. No interference was observed from connnon tablet adjuvants. The accuracy and reliability of the methods were further ascertained by recovery experiments via standard-addition procedure.